Survey Reveals Plain-Language Commitments Still Evolving

TrialScope recently completed a brief phone survey with a group of trial sponsors that have previously made public commitments to plain (lay) language summaries. The summary of results follows:

Scope

Most sponsors are committing to providing plain-language summaries for Phase 2 – 4 studies, some extending the commitment to Phase 1 studies in patients.

Only one surveyed sponsor regularly provides summaries for Phase 1a studies in healthy volunteers, with one other sponsor currently including a few Phase 1a (healthy volunteer) studies in a mix of studies to test the authoring processes. However, most sponsors are waiting for the EU regulations to take effect to write summaries for Phase 1a studies.

Only one sponsor is considering plain-language summaries for non-interventional studies, though this commitment has not yet been finalized.

Timing

Most sponsors are still evolving their plain-language commitments. The broadest commitment we found during our survey was a sponsor that provides summaries for all studies since 2005 of approved compounds marketed in any country plus study supporting any submission since 2015. Only a few organizations appeared to have commitments to provide plain-language summaries for older studies such as any study Phase 1 – 4 study started since April 2015, or Phase 1 – 4 interventional studies completed since December 2015.

Many organizations are still developing their processes by selecting a few representative trials for each therapeutic area (or a random selection) but waiting for the go-live of the EU portal to make any further commitments.

The most common approach is to provide summaries for Phase 2 – 4 studies 12 months after study completion (last patient last visit or LPLV), though one organization aligns the summaries with results posting (six months for pediatric in EU, otherwise within 12 months after completion) and another currently provides summaries only after product approval.

Distribution

Most sponsors that currently provide plain-language summaries are posting these on their corporate trial sites. However, a number also are looking at posting copies of their summaries on a multi-sponsor portal, making them easier to find.

Sponsors are increasingly providing “thank you” cards to participants at their last visit during the trial to inform them about the availability of summaries. These cards include information on how to find plain- language summaries, which may include a link to a multi-sponsor portal where the participant can register to receive a notification once the summary is available. Alternatively, sponsors provide the summaries to the investigational sites, expecting these to provide them to participants (though this may incur additional costs and may not work well for all long-running trials).

Because participants and patients may be eager to hear how the trial is progressing, some sponsors are exploring more frequent communication, including plain-language summaries of interim results.

One suggestion from the survey was to provide participants in later-stage trials with summaries from earlier trials, for example, providing summaries from Phase 2 studies during the consent process.

While there are no firm commitments from any sponsor yet, a few organizations are assessing options for providing patients with personalized results that include information on their participation in the study. Spain already gives participants the right to receive results on genomic tests; other agencies may request this in the future.

Depending on the participant demographics, a video, comic book, or other media presentation may be more effective in communicating results as an alternative or supplement to a written plain-language summary. We have not found any sponsor making a firm commitment to this yet, but a number are exploring these options.

Concerns

Some sponsors are concerned that plain-language summaries might constitute pre-publication, especially for compounds in early phase studies. Because there is no clear guidance from the International Committee of Medical Journal Editors (ICMJE) regarding these summaries, at least one surveyed organization is withholding summaries until after the first publication.

Complicating the issue for Phase 1 studies is that medical writers/publications are often not in the core team for Phase 1. This presents the challenge of confirming that the Phase 1 summaries do not include commercially confidential information (CCI) or otherwise undisclosed information.

The European Medicines Agency (EMA) will require sponsors to provide plain-language summaries for pediatric studies within six months of study completion. Sponsors are concerned that this is not enough time to author the summary in English and to translate it to the various languages of the study. The tight timeline will require the sponsor to draft the summary based on the draft clinical study report (CSR) and then finalize in parallel with the CSR.

About the Author

Thomas is responsible for tracking regulatory and market trends that shape TrialScope’s clinical trial disclosure and transparency solutions. He has more than 23 years of experience with performance and content management solutions, specializing in applications for life sciences such as clinical trial disclosure, structured product labeling and submissions management. Thomas has been focused on trial transparency since 2007.